Evaluating the Safety of and Immune Response to an HIV Vaccine in Healthy, HIV-Uninfected Adults in Uganda

NCT01549509 | Completed Phase 1 DMC

• 2 other identifiers: RV 156A10469
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The RV 156A clinical trial is evaluating an experimental HIV vaccine in people who are not infected with HIV. Participants in that study are randomly assigned to receive either the HIV vaccine or placebo. This study will enroll people who are participating in the RV 156 study. In this study, researchers will evaluate the safety of and immune response to a different experimental HIV vaccine in people who participated in the RV 156 study.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (4)

• Local reactogenicity signs and symptoms

  Measured through Day 336

• Systemic reactogenicity signs and symptoms

  Measured through Day 336

• Laboratory measures of safety

  Measured through Day 336

• Adverse and serious adverse experiences

  Measured through Day 336

Study Arms (1)

VRC-HIVADV014-00-VP Vaccine

EXPERIMENTAL

All participants will receive one injection of the study vaccine (VRC-HIVADV014-00-VP) in their upper arm at study entry.

Biological: VRC-HIVADV014-00-VP Vaccine

Interventions

VRC-HIVADV014-00-VP Vaccine BIOLOGICAL

All participants will receive one injection in their upper arm of 1 x 10\^10 particle units (PU)/mL of VRC-HIVADV014-00-VP at study entry.

VRC-HIVADV014-00-VP Vaccine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 40 years old at the time of RV 156 enrollment
• Available for follow-up for the duration of the study (13 months)
• Satisfactory completion of an Assessment of Understanding prior to enrollment, defined as 90% correct with three opportunities to take the test
• Able and willing to sign the informed consent form
• Willing to receive HIV counseling and testing in accordance with Ugandan Ministry of Health guidelines
• Willing to not engage in high-risk behavior for HIV infection during the study as defined by the protocol and amenable to risk-reduction counseling and discussion of HIV infection risks
• In good general health
• Physical examination and laboratory results without clinically significant findings within 45 days prior to rAd5 boost injection
• Have participated in RV 156 and received all three required vaccinations
• Laboratory Criteria within 45 days prior to enrollment:
• Hemoglobin greater than 11.0 g/dL for women and 12.5 g/dL for men or accompanied by site physician approval and above the site's lower limit of normal (LLN) range
• White blood cell count (WBC) of 3,300 to 12,000 cells/mm\^3 (in the absence of clinical or pathological etiology)
• Absolute neutrophil count (ANC) within the institutional normal ranges and greater than or equal to 1,000 cells/mm\^3 or accompanied by site physician approval
• Total lymphocyte count greater than 800 cells/mm\^3
• Platelets equal to 125,000 to 550,000 cells/mm\^3

You may not qualify if:

• Pregnant, breastfeeding, or planning to become pregnant during the period of study participation
• Immunosuppressive or cytotoxic medications within the past 6 months with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis
• Blood products within 120 days prior to HIV screening
• Immunoglobulin within 60 days prior to HIV screening
• Live attenuated vaccines within 30 days prior to initial study vaccine administration
• Investigational research agents within 30 days prior to initial study vaccine administration
• Medically indicated subunit or killed vaccines, e.g., influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration
• Current anti-tuberculosis (TB) prophylaxis or therapy
• People with a history of any of the following clinically significant conditions will be excluded:
• Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
• Autoimmune disease or immunodeficiency
• Asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years. Asthma that has required the use of oral or intravenous corticosteroids during the past 2 years.
• Diabetes mellitus (type I or II), with the exception of gestational diabetes
• Thyroid disease, including history of thyroidectomy and diagnoses that required medication within the past 36 months
• Serious angioedema episodes within the previous 36 months or requiring medication in the previous 2 years

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Makerere University Walter Reed Project (MUWRP)

Kampala, Uganda

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Fred Wabwire-Mangen, MBChB, PhD

  Makerere University Walter Reed Project

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Start: April 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: October 1, 2009
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

UG (1)